Azurion 7 System
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Azurion 7 M20 |
Not applicable. |
722 224 |
Azurion 7 B20 |
Not applicable. |
722 226 |
Azurion 5 M20 |
Not applicable. |
722228 |
Azurion 7 B12 |
Not applicable. |
722 067 |
Azurion 7 M12 |
Not applicable. |
722 223 |
Azurion 5 M12 |
Not applicable. |
722 227 |
Issue
Philips has become aware of a potential safety issue with the Philips Azurion Systems R1.0, R1.1, R1.2, R2.0, R2.1, and R2.2, where the system may exhibit a loss of imaging functionality and data. Philips has identified a potential issue which can cause the system to continuously restart (restart loop). T his is likely to occur when the patient database gets too big over time (>500 studies). If this issue occurs, a potential for data loss may be expected.
Recall start date: December 15, 2023
Additional information
Details
Philips Medical Systems Nederland B.V.
Veenpluis 6, Best, Netherlands, 5684 PC
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